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ARGATROBAN

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Argatroban Adverse Events Reported to the FDA Over Time

How are Argatroban adverse event reports trending over time?

This graph shows volume of adverse events submitted to the FDA by quarter for Argatroban, as well as related generic and/or brandname drugs containing the same primary active ingredients. Adverse events are counted if Argatroban is flagged as the suspect drug causing the adverse event.

Most Common Argatroban Adverse Events Reported to the FDA

What are the most common Argatroban adverse events reported to the FDA?

International Normalised Ratio Incr...
92 (3.8%)
Activated Partial Thromboplastin Ti...
82 (3.39%)
Coagulation Time Prolonged
71 (2.93%)
Gastrointestinal Haemorrhage
44 (1.82%)
Multi-organ Failure
41 (1.69%)
Haemorrhage
39 (1.61%)
Sepsis
38 (1.57%)
Heparin-induced Thrombocytopenia
35 (1.45%)
Hepatic Function Abnormal
32 (1.32%)
Cerebral Infarction
25 (1.03%)
Hypotension
25 (1.03%)
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Pulmonary Embolism
25 (1.03%)
Deep Vein Thrombosis
24 (.99%)
Thrombocytopenia
24 (.99%)
Alanine Aminotransferase Increased
23 (.95%)
Aspartate Aminotransferase Increase...
22 (.91%)
Rectal Haemorrhage
21 (.87%)
Thrombosis
21 (.87%)
Coagulopathy
20 (.83%)
Pneumonia
20 (.83%)
Pyrexia
18 (.74%)
Haematemesis
17 (.7%)
Renal Failure Acute
17 (.7%)
Atrial Fibrillation
16 (.66%)
Drug Ineffective
16 (.66%)
Haemoglobin Decreased
16 (.66%)
Pulmonary Alveolar Haemorrhage
16 (.66%)
Renal Failure
16 (.66%)
Respiratory Failure
16 (.66%)
Thrombosis In Device
16 (.66%)
Mouth Haemorrhage
15 (.62%)
Haemorrhagic Cerebral Infarction
14 (.58%)
Platelet Count Decreased
14 (.58%)
Cerebral Haemorrhage
13 (.54%)
Unresponsive To Stimuli
13 (.54%)
Cardio-respiratory Arrest
12 (.5%)
Disseminated Intravascular Coagulat...
12 (.5%)
Nausea
12 (.5%)
Overdose
12 (.5%)
Prothrombin Time Shortened
12 (.5%)
Abdominal Pain
11 (.45%)
Activated Partial Thromboplastin Ti...
11 (.45%)
Anaemia
11 (.45%)
Blood Alkaline Phosphatase Increase...
11 (.45%)
Blood Bilirubin Increased
11 (.45%)
Cardiac Arrest
11 (.45%)
Coagulation Time Abnormal
11 (.45%)
Death
11 (.45%)
Drug Interaction
11 (.45%)
Eosinophil Count Increased
11 (.45%)
Hepatic Failure
11 (.45%)
Activated Partial Thromboplastin Ti...
10 (.41%)
Blood Lactate Dehydrogenase Increas...
10 (.41%)
Drug Hypersensitivity
10 (.41%)
General Physical Health Deteriorati...
10 (.41%)
Haemorrhagic Infarction
10 (.41%)
Liver Function Test Abnormal
10 (.41%)
Medication Error
10 (.41%)
Pulmonary Haemorrhage
10 (.41%)
Rhabdomyolysis
10 (.41%)
Septic Shock
10 (.41%)
Vomiting
10 (.41%)
Dyspnoea
9 (.37%)
Epistaxis
9 (.37%)
Hepatic Enzyme Increased
9 (.37%)
Prothrombin Time Prolonged
9 (.37%)
Anaphylactic Shock
8 (.33%)
Cardiac Failure Acute
8 (.33%)
Cerebrovascular Accident
8 (.33%)
Duodenal Ulcer
8 (.33%)
Gamma-glutamyltransferase Increased
8 (.33%)
Gangrene
8 (.33%)
Haematuria
8 (.33%)
Haemodynamic Instability
8 (.33%)
Haemoptysis
8 (.33%)
Shock Haemorrhagic
8 (.33%)
Vena Cava Thrombosis
8 (.33%)
Acute Respiratory Distress Syndrome
7 (.29%)
Blood Fibrinogen Decreased
7 (.29%)
Cerebral Ischaemia
7 (.29%)
Colitis
7 (.29%)
Diarrhoea
7 (.29%)
Haemorrhage Intracranial
7 (.29%)
Hypersensitivity
7 (.29%)
Peritonitis
7 (.29%)
Pneumatosis Intestinalis
7 (.29%)
Pneumothorax
7 (.29%)
Rash
7 (.29%)
Skin Discolouration
7 (.29%)
Subarachnoid Haemorrhage
7 (.29%)
Tonic Convulsion
7 (.29%)
Adenocarcinoma
6 (.25%)
Aneurysm Ruptured
6 (.25%)
Anxiety
6 (.25%)
Bleeding Time Prolonged
6 (.25%)
Blood Pressure Decreased
6 (.25%)
Cardiac Failure
6 (.25%)
Dialysis
6 (.25%)
Dysphagia
6 (.25%)
Fibrin D Dimer Increased
6 (.25%)
Haematocrit Decreased
6 (.25%)

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This graph shows the top adverse events submitted to the FDA for Argatroban, as well as related generic and/or brandname drugs containing the same primary active ingredients, from Q1 2004 to Q3 2012. Adverse events are counted if Argatroban is flagged as a suspect drug causing the adverse event. For each adverse event listed, percent (%) represents percentage of the adverse event to all adverse events reported for the drug. Percent does not represent a rate related to drug utilization.

Adverse Event Categories for Argatroban

What are the most common Argatroban adverse events reported to the FDA?

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This graph shows the top categories of adverse events submitted to the FDA for Argatroban, as well as related generic and/or brandname drugs containing the same primary active ingredients, from Q1 2004 to Q3 2012. Adverse events are counted if Argatroban is flagged as a suspect drug causing the adverse event. For each adverse event listed, percent (%) represents percentage of the adverse event to all adverse events reported for the drug. Percent does not represent a rate related to drug utilization.

Common Uses of Argatroban According to Those Reporting Adverse Events

Why are people taking Argatroban, according to those reporting adverse events to the FDA?

Heparin-induced Thrombocytopenia
321
Cerebral Infarction
43
Anticoagulant Therapy
39
Product Used For Unknown Indication
37
Drug Use For Unknown Indication
35
Deep Vein Thrombosis
29
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Pulmonary Embolism
25
Thrombosis Prophylaxis
16
Embolic Stroke
13
Thrombotic Cerebral Infarction
11
Cerebral Thrombosis
7
Prophylaxis
7
Thrombosis
7
Thrombocytopenia
6
Continuous Haemodiafiltration
5
Antiphospholipid Syndrome
4
Renal Vein Thrombosis
4
Vena Cava Thrombosis
4
Skin Ulcer
4
Coagulopathy
3
Platelet Count Decreased
3
White Clot Syndrome
3
Arteriosclerosis Obliterans
3
Coronary Angioplasty
3
Arterial Occlusive Disease
3
Antithrombin Iii Decreased
3
Ischaemic Stroke
2
Lateral Medullary Syndrome
2
Transient Ischaemic Attack
2
Atrial Fibrillation
2
Thrombosis In Device
2
Embolism
2
Cardiac Operation
2
Heart Valve Operation
1
Percutaneous Coronary Intervention
1
Cerebrovascular Disorder
1
Coronary Artery Bypass
1
Hypertension
1
Coronary Artery Surgery
1
Aortic Thrombosis
1
Myocardial Infarction
1
Orthopedic Procedure
1
Cerebral Ischaemia
1
Platelet Aggregation Abnormal
1
Acute Myocardial Infarction
1
Cardiopulmonary Bypass
1
Basal Ganglia Infarction
1
Atrial Thrombosis
1
Cerebral Artery Embolism
1
Liver Disorder
1
Liver Transplant
1

Drug Labels

LabelLabelerEffective
ArgatrobanEagle Pharmaceuticals, Inc.01-JUN-11
ArgatrobanSandoz Inc27-SEP-11
ArgatrobanWest-ward Pharmaceutical Corp08-MAR-12
ArgatrobanGlaxoSmithKline LLC13-APR-12
ArgatrobanSandoz Inc30-SEP-12

Argatroban Case Reports

What Argatroban safety concerns are being reported by doctors and researchers in the medical literature?

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About Results

This report contains aggregated drug side effects and adverse events for Argatroban. The data has been pulled from the United States Food and Drug Administration's (US FDA) Adverse Event Reporting System (AERS), a database containing more than 4,000,000 adverse event reports.

DrugCite expands your query using the Unified Medical Language System (UMLS) to include generic drugs and primary active ingredients. While the core of DrugCite's advanced drug filtering algorithm is based on the industry standard UMLS, DrugCite's proprietary filtering system also includes dozens of additional steps to reconcile malformed drug names in the FDA's data.

DrugCite only counts a drug if the submitter of the adverse event indicates that the drug is suspected to have caused the adverse event.

Depending on how the data is aggregated, different counts may occur. When someone submits an adverse event to the FDA, the submitter can attribute multiple adverse events to one or more drugs. For example, an individual taking Paxil could submit the adverse events "anxiety" and "suicidal ideation" for the same individual safety report (ISR). This means when DrugCite aggregates by adverse event, two distinct adverse events are counted in the adverse event graph; once for "anxiety" and again for "suicidal ideation". However, when DrugCite aggregates by individual safety reports irrespective of the details of the adverse events contained within the safety report, the report is only counted once.

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